Imaging Innovations

In every clinical trial, data rules. In trials for treatments of solid cancerous tumours, much of that critical data relates to the size, type, and appearance of new lesions, whether used as eligibility criteria or as safety or efficacy endpoints. The importance of having clean, accurate measures and objective interpretations of those measures to the success of an oncology trial cannot be overstated.

Ensuring the validity of imaging data points in oncology trials is particularly challenging due to the complexity and variability in acquiring and assessing images. Protocols must set forth the choice of imaging modality, the image acquisition parameters, and the specific protocol for the IV contrast or oral contrast. This will enable the application of more than 10 different assessment criteria.

Sophie Winandy is Product Manager at ERT and has more than 10 years of experience working closely with clinical trial sponsors and CROs to identify and implement optimal imaging approaches that accelerate the development of new medical products. Drawing on her training as a Registered Technologist, Magnetic Resonance Imaging, Sophie helped to develop the imaging solutions employed by researchers across hundreds of clinical trials during her tenure at Biomedical Systems (acquired by ERT in 2017).

PhlexEarchive: The Right Solution for Electronic Archiving of TMF Content

Phlexglobal Ltd

Many sponsor organizations have already recognized the value of moving from paper to electronic Trial Master Files (eTMFs). But few sponsors have taken a more holistic approach to the TMF lifecycle and looked at the entire process from study start-up through archiving of the TMF in electronic format, also known as e-archiving. The recurring value of managing, tracking, maintaining and accessing electronic files should not stop at the point of archiving. All of the challenges of managing an active paper TMF carry through to a paper archive. All of the benefits of an electronic TMF also carry through to the electronic archive.
As companies look to move their compliance assets to secure, long-term storage, it is important to consider ongoing compliance requirements, security, accessibility, efficiency and costs of archiving TMF content in a digital format.
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SMi is delighted to announce its 3rd Annual Highly Potent
Active Pharmaceutical Ingredients conference coming to London on the 13th-14th
May 2019.
The HPAPI global market has developed rapidly in the past
year and is continuing to expand into the future, with over a quarter of drugs
in development worldwide being classified as highly potent. As a result, there
is a growing demand for both pharmaceutical and contracted manufacturers to
adapt to the evolving HPAPI landscape.
More info >>